UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013328 |
|---|---|
| Receipt number | R000015555 |
| Scientific Title | Effects on glucose metabolism of low-intensity exercise in elderly heart failure patients who have insulin resistance or type 2 diabetes mellitus |
| Date of disclosure of the study information | 2014/03/05 |
| Last modified on | 2019/03/09 16:48:40 |
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Basic information
Public title
Effects on glucose metabolism of low-intensity exercise in elderly heart failure patients who have insulin resistance or type 2 diabetes mellitus
Acronym
Effects on glucose metabolism of low-intensity exercise in elderly patients with heart failure
Scientific Title
Effects on glucose metabolism of low-intensity exercise in elderly heart failure patients who have insulin resistance or type 2 diabetes mellitus
Scientific Title:Acronym
Effects on glucose metabolism of low-intensity exercise in elderly patients with heart failure
Region
| Japan |
Condition
Condition
Heart failure patients with abnormal glucose metabolism
Classification by specialty
| Cardiology | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
For elderly heart failure patients with abnormal glucose metabolism, to verify low-intensity exercise is whether to improve glucose metabolism abnormalities, such as postprandial hyperglycemia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Twenty four hour average blood sugar,prevalence of hyperglycemia over the course of 24h,Incremental area under the curve (IAUC)of 3 hours each postprandial Day, time activity level;amount of physical activity, number of steps, calories, mets
Key secondary outcomes
Full execution rate,Drop-out rate,
Dietary intake,Blood pressure,Pulse
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
All subjects is carried out in a randomized cross-over study to test two of the non-exercise and low intensity exercise.Glycemic control was assessed during the subsequent 24h postexercise and no exercise period by continuous glucose monitoring.All subjects attached a total of 88 hours CGM(Medtronic ipro2).The study carried out in five days, including the washout period.Subjects of A group and was attached with a CGMS on the first day of the 16:00, Implementation for 35 minutes chair exercise is a low-intensity exercise in 9:30 of the second day;1.5to2.5Mets.Washout period of 46 hours after exercise, and rest 35 minutes from 9:30 as a non-exercise day to day 4.CGM removal at 10 the next day 5.The intake respectively 8:00, 12:00, 18:00 in the hospital diet during the study period.At least four daily SMBG measurements are obtained with a gluco-meter(One touch ultra vue,Johnson&Johnson) and enter into the CGMS for calibration.Evaluation of outcomes analyze the data in the Medtronic CareLink iPro software.All subjects are not permitted snacking,and exercise except for intervention during the study period.
Interventions/Control_2
All subjects is carried out in a randomized cross-over study to test two of the non-exercise and low intensity exercise.Glycemic control was assessed during the subsequent 24h postexercise and no exercise period by continuous glucose monitoring.All subjects attached a total of 88 hours CGM(Medtronic ipro2).The study carried out in five days, including the washout period.Subjects of B group and was attached with a CGMS on the first day of the 16:00,Implementation for rest 35 minutes from 9:30 as a non-exercise of the second day.Implementation for 35 minutes chair exercise is a low-intensity exercise in 9:30 of the day3;1.5to2.5Mets.
Washout period of 46 hours after exercise, and CGM removal at 8 the day5.The intake respectively 8:00, 12:00, 18:00 in the hospital diet during the study period.At least four daily SMBG measurements are obtained with a gluco-meter(One touch ultra vue,Johnson&Johnson) and enter into the CGMS for calibration.Evaluation of outcomes analyze the data in the Medtronic CareLink iPro software.All subjects are not permitted snacking,and exercise except for intervention during the study period.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
a.Those who start cardiac rehabilitation in patients with heart failure in the hospital, or have started a rehabilitation already, who has passed for more than fourty eight hours from the previous exercise
b.Age of consent at the time of obtaining 65 years of age or older
c.Patients with HOMA-R> 2.5 or more or type2 diabetes patient (diabetes treatment guiding criterion)
d.There is no change of oral during the period
e.Patient consent was obtained in writing from the person for this study participants
f.Patient with 6MWT<350m
Key exclusion criteria
a. Patients who are considered by the unstable mental state and decrease in comprehension, participation in this study is difficult
b. Unstable patients with hemodynamic NYHA4, degrees arrhythmia control is unstable
c. Severe disease; severe heart failure EF20% less than, severe Aortic stenosis, cirrhosis
d. Patients who can not exercise and walk due to a failure functional by cerebrovascular disease and orthopedic problems
e. Patients with inflammatory active disease
f. Dialysis patient
g.Patients with insulin therapy
h. Patients of 300mg/dl or more fasting blood glucose or urine ketone positive
i. After hepatic resection and post-gastrectomy
j.The patients were determined to be unsuitable for the study by the physician
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuko Nin |
Organization
Kyoto University Graduate School of Medicine,Human Health Sciences
Division name
Clinical Nursing Laboratory
Zip code
Address
53 kawahara-cho,shogoin,sakyo-ku, kyoto
TEL
075-751-3946
nin@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Soong Rae Cho |
Organization
Kyoto University Graduate School of Medicine,Human Health Sciences
Division name
Clinical Nursing Laboratory
Zip code
Address
53 kawahara-cho,shogoin,sakyo-ku, kyoto
TEL
075-751-3946
Homepage URL
cho.soongrae.77u@st.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Graduate School of Medicine,Human Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Osaka Gas Group Welfare Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
京都大学医学部附属病院(京都府)
和泉市立病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 03 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2014 | Year | 01 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 03 | Month | 05 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 16 | Day |
Date of closure to data entry
| 2015 | Year | 01 | Month | 15 | Day |
Date trial data considered complete
| 2015 | Year | 02 | Month | 03 | Day |
Date analysis concluded
| 2015 | Year | 02 | Month | 03 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 03 | Month | 04 | Day |
Last modified on
| 2019 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015555
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